Submission Details
| 510(k) Number | K033056 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2003 |
| Decision Date | January 30, 2004 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
Jan 2004
Decision
123d
Days
Class 2
Risk
About This 510(k) Submission
K033056 is an FDA 510(k) clearance for the BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT, a Electrode, Ion Specific, Urea Nitrogen (Class II — Special Controls, product code CDS), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on January 30, 2004, 123 days after receiving the submission on September 29, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.
Device Classification
| Product Code | CDS — Electrode, Ion Specific, Urea Nitrogen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1770 |
Manufacturer
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